FDA 510(k) Application Details - K214003

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K214003
Device Name	Powder, Porcelain
Applicant	Shenzhen Yurucheng Dental Materials Co., Ltd. 101-201, Building 4, No.1 Branch of Zhongcheng Life Science Park, No. 14 Zhongxing Road Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Fiya Liao Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2021
Decision Date	02/18/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review